Effectiveness and Cost-effectiveness of Telephone-delivered Psychotherapy for Depression in Primary Care

NCT ID: NCT02667366

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-03-31

Brief Summary

The aim of the study is the examination of effectiveness and cost-effectiveness of a telephone-based psychotherapy (Tel-PT) for depression compared to treatment as usual in primary care.

Detailed Description

The overall purpose of the study is to examine the effectiveness of telephone psychotherapy (Tel-PT) for the treatment of mild to moderate depression on different outcome-levels and under clinically representative conditions in Swiss primary health care. The randomized-controlled trial (RCT) will evaluate the primary hypothesis that Tel-PT is more effective than routine primary care (i.e. treatment as usual, TAU), more specifically, that it leads to significant higher reduction in depression severity than TAU at follow-up.

The intervention group (IG) receives a manualized short-term cognitive behavioral treatment, which is the adapted German version of the program "Creating a balance" developed in the USA. The therapy consists of one face-to-face and 8-12 telephone contacts and is carried out by a licensed psychotherapist.

More concrete, recruitment and inclusion of the patients will be carried out by the participating general practitioners (GPs). GPs will be instructed to screen patients at risk for depression, especially those revealing diffuse somatic symptoms and suffering from chronic diseases. If positively screened, patient's depressive symptoms are assessed with Patient Health Questionnaire (PHQ-9) and diagnosed according to ICD-10.

All GPs will receive an initial training prior to their participation, providing them with study information and procedures as well as training in screening procedure, psychodiagnostics and study enrolment.

Eligible patients are provided with detailed study information and asked to participate. Subsequently, patients will give informed consent. Patients will then be included into the study and fill out the baseline questionnaires (t0). After that, randomization will be carried out at the University of Zurich, based on an appropriately created computer algorithm. Both GPs and patients are informed about the results by the study team within two days. Subsequently, patients in control group (CG) will receive regular text messages and patients in the intervention group (IG) will be called by the study therapist to schedule an initial appointment.

In case of positive results, the overarching objective is the optimization of mental health services for depressed patients by implementing an evidence-based, accessible and cost-effective treatment option into primary care.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tel-PT

Tel-PT receives a manualized short-term CBT. Treatment consists of one initial face-to-face appointment and 8-12 subsequent telephone sessions between patient and licensed therapist. Each telephone contact lasts between 20 and 30 minutes and take place on a weekly and later biweekly basis.

Group Type: EXPERIMENTAL

Tel-PT

Intervention Type: BEHAVIORAL

TAU and text messages

Control Group receives treatment as usual and additionally weekly text messages containing general information about depression.

Group Type: ACTIVE_COMPARATOR

TAU and text messages

Intervention Type: BEHAVIORAL

Interventions

Tel-PT

Intervention Type: BEHAVIORAL

TAU and text messages

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• PHQ-9 score of > 5 and ≤15.
• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Minimum age of 18 years
• Diagnosis of mild to moderate depression according to ICD-10 (F32.0, F32.1, F33.0, F33.1)

Exclusion Criteria

• Patients currently being in psychotherapeutic treatment or treatment in past three months
• Suicidal tendencies or suicidality
• Insufficient knowledge of German language
• Health condition that does not allow questionnaire completion

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birgit Watzke, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Zurich, Department of Clinical Psychology and Psychotherapy Research

Locations

University of Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Löwe, B, Spitzer, RL, Zipfel, S, & Herzog, W. Gesundheitsfragebogen für Patienten (PHQ-D): Manual und Testunterlagen. Pfizer. Karlsruhe: 2002.

Reference Type: BACKGROUND

Watzke B, Heddaeus D, Steinmann M, Konig HH, Wegscheider K, Schulz H, Harter M. Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care. BMC Psychiatry. 2014 Aug 20;14:230. doi: 10.1186/s12888-014-0230-y.

Reference Type: BACKGROUND

PMID: 25182269 (View on PubMed)

Simon GE, Ludman EJ, Tutty S, Operskalski B, Von Korff M. Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: a randomized controlled trial. JAMA. 2004 Aug 25;292(8):935-42. doi: 10.1001/jama.292.8.935.

Reference Type: BACKGROUND

PMID: 15328325 (View on PubMed)

Bush, T, Russo, J, Ludman, E, Lin, E, Von Korff, M, Simon, G, Walker, E. Perceived self-efficacy for depression self-management. A reliable and valid self-report measure with predictive validity: Poster presentation at the American Psychological Society Meeting, June 2001. Toronto, Canada.

Reference Type: BACKGROUND

Bullinger, M, & Kirchberger, I. Fragebogen zum Gesundheitszustand. Hogrefe. Göttingen: 1998.

Reference Type: BACKGROUND

Haller E, Besson N, Watzke B. "Unrigging the support wheels" - A qualitative study on patients' experiences with and perspectives on low-intensity CBT. BMC Health Serv Res. 2019 Oct 9;19(1):686. doi: 10.1186/s12913-019-4495-1.

Reference Type: DERIVED

PMID: 31597555 (View on PubMed)

Watzke B, Haller E, Steinmann M, Heddaeus D, Harter M, Konig HH, Wegscheider K, Rosemann T. Effectiveness and cost-effectiveness of telephone-based cognitive-behavioural therapy in primary care: study protocol of TIDe - telephone intervention for depression. BMC Psychiatry. 2017 Jul 19;17(1):263. doi: 10.1186/s12888-017-1429-5.

Reference Type: DERIVED

PMID: 28724423 (View on PubMed)

Other Identifiers

BW-0417

Identifier Type: -

Identifier Source: org_study_id